MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number S-05-080-120-6F

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  Injury  

Event Description

It was reported that a 5x80 mm supera stent was unable to cross the target lesion due to anatomy.Two other supera stents (5x80, 5x100) were used, but the patient went to surgery.The supera stent (5x80) that failed to cross the lesion is not related to the patient going to surgery.Additional event details, including the reason for surgery, are pending.Reportedly, the physician who used the supera stents has not been trained on how to use this device.No additional information was provided.

Event Description

The initial information received indicated there were three supera stents involved.Subsequent to the previously filed medwatch report, additional information was received indicating that there was no third stent involved.The 80 length supera stent failed to cross the anatomy and there was no serious injury that resulted (part 1).After the failure to cross, one 100 length supera stent (part 2) was implanted, then surgically explanted.This device (part s-05-080-120-6f/lot 02099059) was not used in the procedure and no event occurred involving this device.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The other device is being filed under a separate medwatch mfr number.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that three supera stents were involved and were returning; however, subsequent information revealed there were only two supera stents involved - the failure to cross 80 length and the explanted 100 length.No investigation will be performed.This incident, part sequence 3 should not have been filed and it is a duplicate of the failure to cross part sequence.However, since an initial mdr has been filed for the patient going to surgery, this will remain reportable.The other device referenced (100 length, part 2) was filed under a separate medwatch mfr number, 2024168-2014-00940.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3632340
• MDR Text Key: 4184864
• Report Number: 2024168-2014-00941
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: S-05-080-120-6F
• Device Lot Number: 02099059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: SUPERA (5X100); GUIDEWIRE: PROWATER .014 X 300 CM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 125